NARCAN® (naloxone hydrochloride) Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

NARCAN® Nasal Spray is not a substitute for emergency medical care.

Important Safety Information

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride. Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, fever, sweating, runny nose, sneezing, goose bumps (piloerection), yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure and increased heart rate (tachycardia). In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may be characterized by convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.

QUESTIONS?

Find answers to the most frequently asked questions about NARCAN® Nasal Spray.

What pharmacokinetic data is there to support the use of NARCAN® Nasal Spray?

In a pharmacokinetic study in 30 healthy adult subjects, the relative bioavailability (BA) of one nasal spray in one nostril (4 mg total dose, 0.1 mL of 40 mg/mL naloxone hydrochloride solution) and two nasal sprays administered as one nasal spray in each nostril (8 mg total dose, 0.1 mL of 40 mg/mL naloxone hydrochloride solution in each nostril) was compared to a single dose of 0.4 mg naloxone hydrochloride intramuscular injection.

The pharmacokinetic parameters obtained in the study are as follows:

Parameter

4mg – One Nasal Spray in one nostril

8 mg – Two Nasal Sprays, one in each nostril

0.4 mg Intramuscular Injection

(N=29)

(N=29)

(N=29)

tmax (h)*

0.50 (0.17, 1.00)

0.33 (0.17, 1.00)

0.38 (0.08, 2.05)

Cmax (ng/mL)

4.83 (43.1)

9.70 (36.0)

0.88 (30.5)

AUCt (hr.ng/mL)

7.87 (37.4)

15.3 (23.0)

1.72 (22.9)

AUC0-inf(h*ng/mL)

7.95 (37.3)

15.5 (22.7)

1.76 (22.6)

t1/2 (h)

2.08 (29.5)

2.10 (32.4)

1.24 (25.9)

*tmax reported as median (minimum, maximum)

Why the 4 mg dose?

The 4 mg dose in NARCAN® Nasal Spray was selected based on results from studies conducted in collaboration with the National Institute on Drug Abuse (NIDA). In clinical trials conducted to support the approval of NARCAN® Nasal Spray, administration of the drug in one nostril delivered approximately the same levels or higher of naloxone as a single dose of an FDA-approved naloxone intramuscular injection, and achieved these levels in approximately the same time frame.

How can I order NARCAN® Nasal Spray?

First responder organizations (EMS, law enforcement and fire departments) and community based naloxone distribution programs will be able to get NARCAN® Nasal Spray from authorized wholesalers, distributors and pharmacies.

The safety and effectiveness of NARCAN® Nasal Spray has been established in pediatric patients for known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Use of naloxone hydrochloride in pediatric patients is supported by evidence from adequate and well-controlled studies of naloxone hydrochloride in adults with additional data from 15 clinical studies (controlled and uncontrolled) in which neonates and pediatric patients received parenteral naloxone hydrochloride in doses ranging from 0.005 mg/kg to 0.01 mg/kg. Safety and effectiveness are also supported by use of other naloxone hydrochloride products in the postmarketing setting, as well as data available in the medical literature and clinical practice guidelines. NARCAN® Nasal Spray may be administered to pediatric patients of all ages.

Absorption of naloxone hydrochloride following intranasal administration in pediatric patients may be erratic or delayed. Even when the opiate-intoxicated pediatric patient responds appropriately to naloxone hydrochloride, he/she must be carefully monitored for at least 24 hours, as a relapse may occur as naloxone hydrochloride is metabolized. In opioid-dependent pediatric patients (including neonates), administration of naloxone hydrochloride may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life threatening, if not recognized, and should be treated according to protocols developed by neonatology experts.

In settings such as in neonates with known or suspected exposure to maternal opioid use, where it may be preferable to avoid the abrupt precipitation of opioid withdrawal symptoms, consider use of an alternate naloxone containing product that can be dosed according to weight and titrated to effect.

Also, in situations where the primary concern is for infants at risk for opioid overdose, consider whether the availability of alternate naloxone-containing products may be better suited than NARCAN® Nasal Spray.

What are the side effects associated with the use of NARCAN® Nasal Spray?

The following adverse reactions were observed in a clinical study of NARCAN® Nasal Spray:

Increased blood pressure

Constipation

Toothache

Muscle spasms

Musculoskeletal pain

Headache

Nasal dryness

Nasal edema

Nasal congestion

Nasal inflammation

Rhinalgia

Xeroderma

Adverse reactions have been identified during post-approval use of naloxone hydrochloride in the postoperative setting:

Hypotension

Hypertension

Ventricular tachycardia and fibrillation

Dyspnea

Pulmonary edema

Cardiac arrest

Death, coma and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in postoperative patients have resulted in significant reversal of analgesia and have caused agitation.

Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated signs and symptoms of opioid withdrawal including:

Body aches

Fever

Sweating

Runny nose

Sneezing

Piloerection

Yawning

Weakness

Shivering or trembling

Nervousness, restlessness or irritability

Diarrhea

Nausea or vomiting

Abdominal cramps

Increased blood pressure

Tachycardia

In some patients, there may be aggressive behavior upon abrupt reversal of an opioid

In the neonate, opioid withdrawal signs and symptoms also included:

Convulsions

Excessive crying

Hyperactive reflexes

Are there any contraindications?

Patients should not use NARCAN® Nasal Spray if they are allergic to naloxone hydrochloride or any other ingredients:

Benzalkonium chloride (preservative)

Disodium ethylenediaminetetraacetate (stabilizer)

Sodium chloride

Hydrochloric acid (to adjust pH)

Purified water

Are there any other safety considerations concerning the use of NARCAN® Nasal Spray?

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NARCAN® NASAL SPRAY AFFORDABILITY

Affordability and access to NARCAN® Nasal Spray are important priorities for ADAPT Pharma, and we have partnered with all major wholesalers, distributors, and retail pharmacies to ensure broad-based availability. For NARCAN® Nasal Spray, ADAPT Pharma has collaborated with major Pharmacy Benefits Managers and insurance companies (including Medicaid), to help make sure the cost of NARCAN® Nasal Spray to insured patients and caregivers is reasonable and affordable.

For your patients, their caregivers and individual purchasers:

Many insured patients, caregivers, and individuals can purchase NARCAN® Nasal Spray for $10 or less. In fact, 94% of insured lives in the US have coverage for NARCAN® Nasal Spray*. And according to IMS Health, nearly three quarters (74%) of prescriptions for NARCAN® Nasal Spray have a co-pay of $10 or less**. For those who choose to pay by cash, ADAPT Pharma has partnered with retail pharmacies to make NARCAN as affordable as possible.

Find a NARCAN participating pharmacy near you

ADAPT Pharma has partnered with all major wholesalers, distributors, and retail pharmacies to make NARCAN® as accessible and affordable as possible. And at many locations, your patients DO NOT NEED A PRESCRIPTION to obtain NARCAN Nasal Spray. Enter your zip code for a listing of NARCAN® participating pharmacies — then call ahead for information on pricing, copays, and whether you will need a prescription.

FOR QUALIFYING GROUP PURCHASERS:

To expand community access, NARCAN® Nasal Spray is available to all qualified group purchasers for $37.50 per 4mg dose ($75 per carton of 2 doses). This pricing is available for all Qualified Group Purchasers, such as first responders (EMS, Fire Department, Police), community organizations and Departments of Health, regardless of size. This pricing represents a 40% discount off the Wholesale Acquisition Cost (WAC) of $125 per carton.

If you would like to make a group qualified purchase, click here.

Additional Resources

NARCAN® (naloxone hydrochloride) Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

NARCAN® Nasal Spray is not a substitute for emergency medical care.

Important Safety Information

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride. Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, fever, sweating, runny nose, sneezing, goose bumps (piloerection), yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure and increased heart rate (tachycardia). In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may be characterized by convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.

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